About this trial
This is a multicenter, prospective study of Pralatrexate combined with Chidamide bridging Allogeneic Hematopoietic Stem Cell Transplantation for Refractory/Relapsed Peripheral T-cell Lymphoma
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients fully understand the study, voluntarily participate in and sign on the informed consent;
Diagnosed by histopathology Peripheral T-cell lymphoma;
ECOG PS score 0 or 1;
Relapsed or Refractory Peripheral T Cell Lymphoma;
Disqualifiers
NK/T-cell lymphoma;
Achieving CR or PR after induction chemotherapies without relapse;
Dysfunction of vital organs;
Serious history of autoimmune diseases and immunodeficiency, including: positive for human immunodeficiency virus (HIV) antibodies; Or other acquired or congenital immunodeficiency diseases; Or have a history of organ transplantation;
Trial design
Single group
Treatments tested in this trial
Pralatrexate combined with Chidamide bridging Allogeneic Hematopoietic Stem Cell Transplantation
Other interventionDrug: Pralatrexate, Chidamide 1. Pralatrexate: 30 mg/m2 intravenously (IV) administered weekly in 6-week cycles. Chidamide: 20mg, twice a week in 3-week cycles (2 weeks on treatment, 1 week off treatment) 2. After the 6-week therapy, the patients should receive PET/CT evaluation. 3. Patients would receive allo-HSCT if they could achieve at least PR after the first cycle of therapy. For the patients could not achieve a least PR after the first cycle of therapy, they should receive a second cycle of pralatrexate combined with chidamide. The interval between two cycles of pralatrexate combined with chidamide should be at least 1 week. 4. After the second cycle of 6-week therapy, the patients should receive PET/CT evaluation. Patients would receive allo-HSCT if they could achieve at least SD after the second cycle of therapy. For the patients could not achieve a least SD after the second cycle of therapy, they should receive other salvage therapies.
Treatment groups
Trial outcomes
Primary outcomes
Progression-free survival (PFS) at 1 year after transplantation
The time from the end of transplantation to progression of disease or death at 1year
Sponsors and contacts
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Peking University People's Hospital
Lead sponsor
Ruijin Hospital
Collaborator
Wuhan TongJi Hospital
Collaborator
West China Hospital
Collaborator
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